Clinical Benefit of Topoisomerase Downregulation
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|ClinicalTrials.gov Identifier: NCT00250094|
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : September 7, 2011
1.1 To determine the regulation of topoisomerase I and II following alternating prolonged exposure to topotecan and etoposide (VP-16)
1.2 To determine the time to progression and the objective response rate of this treatment in patients with incurable ovarian cancer.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Topotecan and VP16||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Benefit of Topoisomerase Downregulation: A Phase I Pilot Study|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||March 2006|
U.S. FDA Resources
Drug: Topotecan and VP16
Course 1A: On day 1 treatment will start with a continuous infusion of TPT at 0.4 mg/m2/day for 21 days. A pump will be used to deliver the TPT. The bag in the pump will be replaced every week for sterility precautions.
Course 1B: On day 28, if ANC is >1,500 and platelets > 100,000, VP-16 will be administered orally at 50 mg/day for 14 days.
- To determine the regulation of topoisomerase I and II following alternating prolonged exposure to topotecan and etoposide (VP-16) [ Time Frame: 3 years ]
- To determine the time to progression and the objective response rate of this treatment in patients with incurable ovarian cancer [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250094
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Claire F Verschraegen, MD||University of New Mexico|